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MK-1942 for Major Depressive Disorder
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15: 12 (daily dose) or 72 (intermittent dose) hours postdose
Summary
This trial is testing a new drug called MK-1942 to see if it helps people with depression that doesn't improve with regular treatments. The goal is to find out if MK-1942 can reduce depression symptoms.
Eligible Conditions
- Major Depressive Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15: 12 (daily dose) or 72 (intermittent dose) hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15: 12 (daily dose) or 72 (intermittent dose) hours postdose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in MADRS Total Score to Week 1
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3
Number of Participants Who Discontinued Study Treatment Due to an AE
+1 moreSecondary study objectives
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 1
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3
Change From Baseline in the HAM-D17 Scale Total Score to Week 1
+2 moreSide effects data
From 2022 Phase 1 trial • 27 Patients • NCT0430830413%
Nausea
7%
Dyspepsia
7%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
7%
Pruritus
7%
Nystagmus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Bid
MK-1942 50 mg BID & Days
MK-1942 8 mg BID 7 Days
MK-1942 30 mg Bid 7D
MK-1942 15 mg BID 7 Days
MK-1942 Total
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-1942 Intermittent Dose GroupExperimental Treatment2 Interventions
Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Group II: MK-1942 Daily Dose GroupExperimental Treatment2 Interventions
Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Group III: PlaceboPlacebo Group1 Intervention
Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1942
2021
Completed Phase 1
~30
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,123 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,010 Previous Clinical Trials
5,185,144 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,885 Previous Clinical Trials
8,088,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have struggled with substance abuse or addiction in the past year or currently.You have HIV or unstable conditions like hypothyroidism, diabetes, heart problems, or lung problems.You are currently going through a period of moderate to severe depression.You are allergic to any of the ingredients in the medication MK-1942.You have tried 1 to 4 different antidepressant medications for your current episode of moderate-to-severe depression, but they did not work well enough for you.You have been experiencing depression for more than 2 years without any significant improvement.You have not had electroconvulsive therapy, deep brain stimulation, or vagal nerve stimulation for treating depression in the past 10 years.You are a female and at least one of the following conditions apply: You are not pregnant or breastfeeding, and you are aged 18 years or older.You didn't get better after trying ketamine or esketamine for your depression in the past.You are currently at a high risk of hurting yourself or others.You drink more than 3 alcoholic drinks every day. A standard drink is a beverage that contains 14 grams of pure alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: MK-1942 Daily Dose Group
- Group 2: MK-1942 Intermittent Dose Group
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04663321 — Phase 2
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